Drug Safety Developments

Birth Control Pills Series: Are the Current FDA Label Warnings Enough?

 

Written by: Heather Helmendach, Legal Assistant 
Law Offices of Thomas J. Lamb, P.A.

 

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Series Overview:

Article 1 - Creating a Clinical Disorder for Profit
Article 2 - The Devastating Side Effects
Article 3 - Are the Current FDA Label Warnings Enough?

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In the previous article of my blog series on Yaz, Yasmin, Ocella, Gianvi, Safyral, and Beyaz, I discussed the devastating side effects that can result from using these DRSP-containing birth control pills.  

For my final article in this series, I will discuss the current drug label warnings for these drugs, and contemplate whether these warnings are sufficient.

As discussed in my previous article, studies conducted in 2009, as well as the FDA findings in 2012 led to a label change for the DRSP-containing birth control pills. The 2012 drug label warned that the risk of venous thromboembolism (VTE) is greater among those who use DRSP-containing birth control pills such as Yaz, Yasmin, Ocella, Gianvi, Safyral, and Beyaz.

In spite of this new warning, there have been "more than 10,800 adverse events reported to [the] FDA by health professionals and manufacturers" concerning DRSP birth control pills, according to the article, "Lawsuits Follow PMDD Diagnosis: Lowering the Bar."  Furthermore, 6,000 of those reports involved hospitalizations, and 200 reports involved deaths.

Unfortunately, tragic stories of women using these DRSP birth control pills are far from scarce.  One woman's story is discussed in the aforementioned article, and involves twenty-nine year-old, Oconomowoc native, Cayla Hibbard.  Hibbard took Yasmin as a means of birth control and alleviating severe menstrual symptoms.  When she started taking Yasmin, Hibbard lived an active lifestyle and was going to school for massage therapy.  

However, one day, she was hospitalized after experiencing difficulty breathing while climbing stairs.  She was diagnosed with a pulmonary embolism, which is a potentially fatal blood clot in the lungs.  As a result, Hibbard had to use blood thinning medications for approximately six months after her diagnosis.    

Hibbard filed a lawsuit against Bayer claiming that they "knew or should have known that Yasmin was being used to treat menstrual symptoms, even though it is not approved for that.  The lawsuit also argued the company fraudulently concealed the safety risks of the drug in order to induce doctors to prescribe it."

There are thousands of women like Hibbard who have also experienced devastating side effects after using these DRSP birth control pills.  While Hibbard survived this terrible episode, other women who used these birth control pills have not been so fortunate.  Since the late 2000s, more than 12,000 women in America have filed lawsuits against Bayer for injuries or deaths resulting from use of Yaz and Yasmin, alone.  In addition, many more lawsuits have been filed against Bayer by women who used Safyral, Beyaz, Ocella, and Gianvi for similar devastating side effects.

Given that such a large number of women are still suffering from life-threatening side effects resulting from DRSP birth control pills, it may be time for the FDA to strengthen their warnings.  It seems as though the warnings added to the drug labels for the DRSP birth control pills in 2012 are not sufficient.  How many more women need to suffer before the FDA releases a new label change, bearing stronger warnings?  

Do you have a story similar to Cayla Hibbard, and the thousands of other women who have suffered due to Yaz, Yasmin, Ocella, Gianvi, Safyral, or Beyaz?  Tell us about it by leaving a comment, or by completing a free case evaluation.

We will continue to monitor the medical literature concerning Yaz, Yasmin, Ocella, Gianvi, Safyral, and Beyaz, and hope to see a new label change in the near future for these birth control pills.

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

 

Birth Control Pills Series: The Devastating Side Effects

 

Written by: Heather Helmendach, Legal Assistant 
Law Offices of Thomas J. Lamb, P.A.

 

---

Series Overview:

Article 1 - Creating a Clinical Disorder for Profit
Article 2 - The Devastating Side Effects
Article 3 - Are the Current FDA Label Warnings Enough?

---

 

The first article of my blog series on Yaz, Yasmin, Ocella, Gianvi, Safyral, and Beyaz discussed how Yaz in particular was marketed to treat premenstrual dysphoric disorder (PMDD)--before PMDD was even classified as a medical condition--so that the drug manufacturer, Bayer, could increase their profits.

In this article, I will provide information on the prescription of birth control pills that contain drospirenone (DRSP), such as those listed above, and the devastating side effects that can result from using them.  

While Yaz, Yasmin, Gianvi, and Beyaz are approved to treat PMDD, none of the DRSP-containing birth control pills are approved by the FDA to treat PMS symptoms. In fact, the trials conducted by the company showed that these DRSP-containing drugs are scarcely more effective than a placebo.

However, that certainly didn't stop Bayer from marketing them as such.  The FDA responded by issuing a warning letter against Bayer in 2008, stating that they were falsely advertising that Yaz could be used to treat and completely eliminate symptoms of PMS.      

Not only did Bayer market Yaz to treat a condition that it was not approved for, but they also claim that the DRSP birth control pills they manufacture do not increase the risk of blood clots, though the medical evidence strongly suggests otherwise.

For example, in 2009, the studies "The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type" and "Hormonal contraception and risk of venous thromboembolism" showed that use of DRSP-containing birth control pills do, in fact, lead to an increased risk of blood clots.

Here is an excerpt from the "Results" section of the first article's abstract:

Currently available oral contraceptives increased the risk of venous thrombosis fivefold compared with non-use (odds ratio 5.0, 95% CI 4.2 to 5.8). The risk clearly differed by type of progestogen and dose of oestrogen. The use of oral contraceptives containing levonorgestrel was associated with an almost fourfold increased risk of venous thrombosis (odds ratio 3.6, 2.9 to 4.6) relative to non-users, whereas the risk of venous thrombosis compared with non-use was increased...6.3-fold for drospirenone (6.3, 2.9 to 13.7). [Emphasis added].

The "Conclusion" section of the second article's abstract provides the following information:

The risk of venous thrombosis in current users of combined oral contraceptives decreases with duration of use and decreasing oestrogen dose. For the same dose of oestrogen and the same length of use, oral contraceptives with desogestrel, gestodene, or drospirenone were associated with a significantly higher risk of venous thrombosis than oral contraceptives with levonorgestrel.

Furthermore, according to the article, "Lawsuits Follow PMDD Diagnosis: Lowering the Bar," in 2012, "an FDA safety review found that the birth control drugs might increase the risk of blood clots by as much as threefold, compared with other hormonal birth control pills." 

Here is a current list of side effects that have been associated with birth control pills that contain DRSP:

• Blood Clots
• Deep Vein Thrombosis (DVT)
• Pulmonary Embolism (PE)
• Stroke
• Cerebrovascular Accidents (CVA)
• Heart Attack
• Myocardial Infarction
• Death

Have you experienced any of these side effects after using Yaz, Yasmin, Ocella, Gianvi, Safyral, or Beyaz?  If so, tell us about it by leaving a comment, or by completing a free case evaluation.

The final article in this series will discuss the current FDA drug label warnings concerning these side effects, and whether such warnings are sufficient.

In the meantime, we will continue to monitor the medical literature on Yaz, Yasmin, Ocella, Gianvi, Safyral, and Beyaz.  You can also learn more about these DRSP-containing birth control pills on our website.

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

Birth Control Pills Series: Creating a Clinical Disorder for Profit

 

Written by: Heather Helmendach, Legal Assistant 
Law Offices of Thomas J. Lamb, P.A.

 

---

Series Overview:

Article 1 - Creating a Clinical Disorder for Profit
Article 2 - The Devastating Side Effects
Article 3 - Are the Current FDA Label Warnings Enough?

---

 

To start my blog series on Yaz, Yasmin, Ocella, Gianvi, Safyral, and Beyaz, I will focus on Yaz in particular, and one of the conditions that it is prescribed to treat.

Though drugs are generally created for the purpose of treating existing medical conditions, this is not always the case.  In fact, corruption in the system can sometimes result in the creation of a medical condition after the approval of the drugs designed to treat it.  This provides drug companies with a way to deepen their pockets by expanding the market potential of their drugs.

This very phenomenon occurred with the treatment of "premenstrual dysphoric disorder" (PMDD) by prescribing Yaz and several antidepressants.  More details are provided in the article "Lowering the Bar: How PMDD Went from an Idea to a Diagnosis" by John Faubner, whose information is referenced and summarized in this post.

PMDD is a severe form of PMS, and Faubner provides the following information in his article:

"According to the DSM, which recognized PMDD as a disorder in 2013, the condition is defined as having at least 5 of 11 symptoms, which include feeling angry, irritable, depressed, or anxious, and having mood swings.

Several antidepressants were approved for the treatment of "the not-yet-existent diagnosis of PMDD in 2000"; just two years after a private meeting was paid for by the drug manufacturer, Eli Lilly, and conducted by four of its executives along with various researchers and six FDA officials.  Yaz was later approved as a treatment for PMDD in 2006.

However, PMDD was not formally considered a distinct psychiatric condition by the American Psychiatric Association until 2013.  Even then, its validity was still questioned by some medical professionals, and the majority of the members on the panel responsible for the decision had ties to drug companies.

In addition, the numbers of women who supposedly had PMDD were severely inflated.  While initial reports in 2011 touted that 30% of women have PMDD, later studies determined that only 1.3% of premenopausal women have PMDD.  That means that initially, 6 million women were thought to have PMDD, when in actuality, the number was just under 1 million.

The previously-referenced article by Faubner includes the following information provided by Amanda LaFleur, executive director of the National Association for Premenstrual Dysphoric Disorder:

[For] many women the only other approved drug, Yaz, only made symptoms worse.

In two clinical trials, Yaz reduced PMDD symptoms, but not a lot more than a placebo.

Women who took Yaz showed a 37.5-point improvement on a symptom scale that had a maximum of 126 points, but those who get a placebo had a 30-point improvement.

And the drug's effectiveness beyond three menstrual cycles is not known.

Faubner also includes statements by Diana Zuckerman, PhD, president of of the National Center for Health Research:

Treating PMDD with birth control pills, such as Yaz, that include the drug drospirenone is especially concerning...

The drug's label warns that women over 35 who smoke should not use Yaz, because of the risk of clots and the increased likelihood of a serious cardiovascular event.

"Safer drugs are available to effectively treat PMDD," Zuckerman said. "How bad is your PMDD that you are willing to put your life at risk?"

The next article in my Yaz, Yasmin, Ocella, Gianvi, Safyral, and Beyaz series will provide information on some of the lawsuits that have previously been filed due to complications of these drugs following their approval for PMDD treatment.

In the meantime, we will continue to monitor the medical literature concerning these drugs, and more information can be found on our website.

 

Drug Injury Watch: Side Effects News & Reports

Drug Injury Law: Medical & Legal Information

Lawsuits pile up over popular birth control pill

Quoted from http://www.chicagotribune.com/health/ct-met-birth-control-risks-20130915,0,765904,full.story

Lawsuits pile up over popular birth control pill

FDA says contraceptives containing drospirenone may pose greater blood clot risk; industry-funded studies, some physicians say drugs are very safe

 By Julie Deardorff, Chicago Tribune reporter

September 15, 2013

Peotone's Maggie Yunker had been taking birth control pills for a year when her doctor suggested switching to a brand that also could clear up acne and ease some aggravating symptoms related to her period.

Yunker was sold. But a year later, the 20-year-old suffered a life-altering stroke after multiple blood clots formed, broke free and lodged in her brain.

Though all oral contraceptives slightly increase the chance of developing blood clots in the legs and lungs, Yunker was taking Yaz, part of a newer generation of pills that the U.S. Food and Drug Administration says may pose a greater risk than similar types of birth control.

[Article continues at original source]

Related articles

YAZ / Yasmin / Ocella / Gianvi Blood Clot Lawsuits That Are Not Settled Yet: Number Increases, Indicating That These Legal Claims Continue To Be Filed In 2013

Higher Risk Of Venous Thrombosis - Blood Clot Side Effects Like DVT And PE With YAZ / Yasmin Birth Control Pills Is Confirmed By September 2013 BMJ Medical Journal Article

Beauty queen Georgie Holland claims Yasmin pill caused a stroke

Quoted from http://www.dailymail.co.uk/health/article-2416856/Beauty-queen-Georgie-Holland-claims-Yasmin-pill-caused-stroke.html

'The Pill gave me a stroke': Beauty queen, 18, claims Yasmin caused a blood clot in her brain - and damaged her vision

• Georgie Holland was picked up early from school after feeling faint
• At home her condition deteriorated quickly
  
• She became confused, her speech was slurred and she struggled to see
• She was rushed to hospital where she was diagnosed with a stroke
• She had no other risk factors so doctors think The Pill might have contributed
  

By Emma Innes

PUBLISHED: 12:57 EST, 10 September 2013

A teenager has been left partially blind after suffering a stroke linked to the contraceptive pill.

Georgie Holland, 18, collapsed after being sent home from college and spent two days in bed before her parents took her to hospital, where a scan revealed a blood clot in her brain that was affecting the flow of blood.

Doctors linked the stroke to her taking the contraceptive pill Yasmin for two years. Georgie now has limited peripheral vision in her right eye and has to take aspirin every day to thin her blood.

[Article continues at original source]

Related articles

Higher Risk Of Venous Thrombosis - Blood Clot Side Effects Like DVT And PE With YAZ / Yasmin Birth Control Pills Is Confirmed By September 2013 BMJ Medical Journal Article

YAZ / Yasmin / Ocella / Gianvi Blood Clot Lawsuits That Are Not Settled Yet: Number Increases, Indicating That These Legal Claims Continue To Be Filed In 2013

‘Our family is forever changed’

Quoted from http://www.novanewsnow.com/News/2013-06-25/article-3291840/%26lsquoOur-family-is-forever-changed%26rsquo/1

‘Our family is forever changed’

Katelynne “Katt” Fisher died at 18 as the result of a blood clot that, her mother was told, may have been caused by the Yaz birth control pill. (Submitted photo)

Published on June 25, 2013 Ashley Thompson  
The Hants Journal

Falmouth mother joins class action lawsuit against birth control manufacturer

Leah Fisher knows no amount of money will bring her daughter back.

She knows the class-action lawsuit she joined against the makers of the commonly used birth control pill she believes to be linked to her daughter’s death will be a hard-fought battle that could very well end in disappointment.

And, she knows the manufacturers of the multi-billion dollar product could likely handle a multi-million dollar payout to all of the complainants involved in the lawsuit and continue on with business as usual.

What she doesn’t know is why a product that may have played a role in the deaths of multiple Canadian women is still on the market.

Fisher says her daughter, Katelynne, started taking the Yaz birth control pill manufactured by Bayer about one month before she suffered a seizure induced by a large blood clot in her brain.

The 18-year-old spent eight days in a coma, suffered strokes and endured an 11-hour surgery as doctors attempted to break the clot apart. The clot proved to be too large, and Katelynne never regained consciousness.

[Article continues at original source]

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Yaz and Yasmin: An Unacceptable Level of Risk?

Lawsuits over Bayer birth-control device to be concentrated in Bergen County

Summer 2013 Bayer Lawsuits Update: YAZ, Yasmin, Ocella, And Gianvi Lawsuits Continue To Be Settled, With New Cases Being Filed

Yaz and Yasmin birth control pills linked to 23 deaths, say Health Canada documents

Yaz and Yasmin: An Unacceptable Level of Risk?

Quoted from http://msmagazine.com/blog/2013/06/25/yaz-and-yasmin-an-unacceptable-level-of-risk/

Yaz and Yasmin: An Unacceptable Level of Risk?

June 25, 2013 by Elizabeth Kissling

Don’t feel bad if you missed last week’s headline news about the deaths of 23 young women from their birth control. It was a top story for CBC news and a few other Canadian sources, but it was barely a blip on the radar of most U.S. news outlets. Yaz and Yasmin, two similar new-generation birth control pills from Bayer, are suspected in the recent deaths of these young Canadian women.

These are among the best selling oral contraceptives in the world, but this is not the first time Yaz and Yasmin have been suspected of causing death or adverse effects. Earlier this year, Bayer agreed to pay up to $24 million to settle claims from plaintiffs with gall bladder injuries caused by the drugs,and the company set aside $1 billion to settle claims from approximately 4,800 women who have suffered blood clots due to Yaz or Yasmin.As of February, 2013, approximately 10,000 lawsuits against Bayer are still pending in the U.S., and an additional 1,200 unfiled claims are pending. The company anticipates additional lawsuits—and additional settlements—regarding blood clot injuries, such as pulmonary embolisms or deep-vein thrombosis.

[Article continues at original source]

Yaz and Yasmin birth control pills linked to 23 deaths, say Health Canada documents

Quoted from http://www.vancouversun.com/health/Yasmin+birth+control+pills+linked+deaths+Health+Canada+documents/8510364/story.html

Yaz and Yasmin birth control pills linked to 23 deaths, say Health Canada documents

By Sheryl Ubelacker, The Canadian Press June 11, 2013

The popular birth-control pills Yaz and Yasmin have been linked to the deaths of at least 23 Canadian women —the youngest just age 14, Health Canada documents say.

The deaths are among about 600 adverse reactions reported among women taking the contraceptives between 2007 and Feb. 28 of this year, Health Canada confirmed Tuesday.

Doctors and pharmacists who submitted the reports to the Canada Vigilance Program said Yaz and Yasmin are suspected in the 23 deaths. The reports say most of the women died suddenly after developing blood clots, a known risk with the pills.

[Article continues at original source]

EU agency to review safety of newer contraceptive pills | Reuters

Quoted from http://www.reuters.com/article/2013/01/28/us-contraceptives-europe-idUSBRE90R0QM20130128

EU agency to review safety of newer contraceptive pills

LONDON | Mon Jan 28, 2013 12:11pm EST

LONDON (Reuters) - The European Medicines Agency is to review the safety of third and fourth-generation combined oral contraceptives to decide if there is a need to restrict their use.

Monday's move followed a request by France, where authorities have already taken steps to reduce use of the drugs in favor of second-generation birth control pills.

The newer pills, which include Bayer's Meliane or Yasmin, have proved popular because they reduce side effects seen with earlier versions, such as weight gain and acne.

But France wants the European Union regulator to restrict their use because of concerns they carry a higher risk of dangerous blood clots.

While all oral contraceptives are associated with some danger of blood clots, a number of studies suggest the most recent third- and fourth-generation pills carry a higher risk than their predecessors.

[Article continues at original source]

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EU agency sees no new risks with combined contraceptives

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EU agency sees no new risks with combined contraceptives

Quoted from http://www.reuters.com/article/2013/01/11/us-contraceptives-europe-regulator-idUSBRE90A09N20130111

EU agency sees no new risks with combined contraceptive

LONDON | Fri Jan 11, 2013 3:59am EST

LONDON (Reuters) - European drug regulators said on Friday there was no reason for women to stop using combined contraceptives like Bayer's Meliane or Yasmin pills since there was no new evidence pointing to safety risks.

The move comes after French health regulators said last week they were considering limiting use of some birth control pills after a woman sued the German drugmaker over alleged side-effects.

In a statement responding to reports about the so-called "third-generation" contraceptive pills and blood clots known as venous thromboembolisms, the European Medicines Agency (EMA) said it was already well known that the pills "carry a very rare risk of blood clots".

It said that risk differs between types of combined contraceptives.

"These products are constantly and rigorously kept under close monitoring. There is currently no new evidence that would suggest any change to the known safety profile of any combined contraceptives marketed today," the agency said. "There is no reason for any woman to stop using her contraception."

EMA says the risk of a blood clot is twice as high for women using third and fourth-generation pills than for those using earlier versions, although it remains low. The risk of a stroke is the same.

[Article continues at original source]

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Some Newer Contraceptive Methods Such As NuvaRing And YAZ / Yasmin Are Under Increasing Scrutiny Over In Europe

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Swiss health insurer makes claim against Bayer over Yasmin pill